Enhanced standard care for treating mechanical neck pain
Official title: A Two-Center, Investigator-Blinded, Randomized, 4-Week, Parallel-Group, Superiority Study Comparing Contextual Factors-Enriched Standard Care Versus Standard Care Only for Patients With Mechanical Neck Pain (ContextualizAR Trial)
Run by Universidad Nacional de la Matanza · NCT06361472 · Data updated 2026-11-12
This study is testing if adding extra support for physical, mental, and social factors to standard care can help people with neck pain feel better and improve their daily activities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | Universidad Nacional de la Matanza Academic / other |
| Locations | 2 sites (Ciudad Autónoma de Buenos Aires, Buenos Aires and 1 other locations) |
| Status | Recruiting |
| Started | May 2, 2024 |
| Main results expected | April 2027 |
| Study ends | July 2027 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06361472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with neck pain persisting for more than 4 weeks and no major structural pathology.
✕Probably not a fit
Patients with minor neck pain, recent cervical spine trauma, or serious underlying conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a Contextual Factors-Enriched Standard Care (CFs+SC) approach compared to standard care alone for patients suffering from mechanical neck pain. Over a 4-week period, participants will receive treatment twice weekly, with the intervention group benefiting from additional contextual factors that address physical, psychological, and social elements of care. The study will measure outcomes such as pain reduction and functional improvement using validated questionnaires and scales. The trial will also explore the impact of psychosocial conditions on treatment efficacy.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve functional status for patients with mechanical neck pain.
How similar studies have gone: While the specific CFs+SC approach may be novel, similar studies have shown promise in enhancing treatment outcomes through contextual factors.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged \>18. * Neck pain for more than 4 weeks without signs or symptoms suggestive of major structural pathology. * Read, write, and understand the Spanish language. * Signed consent form. Exclusion Criteria: * Numeric Pain Reporting Scale (NPRS) \< 3 points (to ensure the exclusion of patients with minor disorders). * Northwick Park Neck Pain Questionnaire (NPQ) \< 10 points (to ensure the exclusion of patients with minor disorders). * History of cervical spine trauma, fracture, or surgical procedures. * Signs and symptoms of cervical myelopathy and/or cervical radiculopathy (to rule out cervical radicular pain, the Spurling Test, the Upper Limb Tension Test for the median nerve, and the Traction/Distraction test will be used). * Red flags or serious pathologies, such as malignancy, inflammatory or rheumatic diseases, infections, and vascular conditions like cervical artery insufficiency.
Where it's running
-
Hospital Carlos G. Durand
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting -
Hospital Donación Francisco Santojanni
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting
Study contacts
- Principal investigator: Mauro F Andreu, PhD — Universidad Nacional de la Matanza
- Study coordinator: Mauro F Andreu, PhD
- Email: mfandreu@gmail.com
- Phone: (+54) 11 6878-8298
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.